Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insuffici
FDA device recall Z-0839-2013 · posted 2013-02-20 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Reason for recall
- ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.
- Action taken
- Maquet sent Urgent Device Recall Letters/Recall Acknowledgement Forms to their customers on 12/26/2012.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 41 units - US Distirbution; 216 units - OUS Distribution
- Distribution
- Worldwide Distribution-USA including the states of AZ, CO, FL, TN, and TX and the countries of Australia, Canada, Czech Republic, Dubai/Bahrain/Kuwait/Lebanon/Saudi Arabia/Yemen, France, Germany, Hong
- Date initiated
- 2012-12-26
- Date posted
- 2013-02-20
- Date terminated
- 2014-05-08
- Location
- Wayne, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELS CANNULA (KIT), MODEL M1210-88,M1510-88 (K002857) | Jostra AG | 2000-10-05 |